MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER

Catalog Number 14604

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urticaria (2278); Skin Inflammation/ Irritation (4545)

Event Date 01/03/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed over the last 3 years.End user said this is not a lot-specific problem.Since lot number not provided dhr review not possible.Sample not returned so sample evaluation not possible.Patient's race is not known.Root cause of reported skin irritation and itching under the barrier cannot be determined.Hollister is sending samples of a different style of hollister skin barriers (convex) for the end user to try in order to address the report of effluent leakage under the barrier.

Event Description

It was reported that an end user who has been using the hollister new image barrier started experiencing irritated, itchy and discolored skin under her barrier in october.She was prescribed nystatin powder and it cleared up.She started experiencing the same thing recently associated with effluent leakage under the barrier.She has been needing to change the barrier more often because of the leakage which is causing some areas under the barrier to bleed.She again started using nystatin powder and the skin is improving.

• Brand Name: NEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER
• Type of Device: NEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 13285108
• MDR Text Key: 287402365
• Report Number: 1119193-2022-00002
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 102 KG